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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K093098
Device Name AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
Applicant
Arkray, Inc.
1201 Richardson Dr.
Suite 140
Richardson,  TX  75080
Applicant Contact KENNETH L BLOCK
Correspondent
Arkray, Inc.
1201 Richardson Dr.
Suite 140
Richardson,  TX  75080
Correspondent Contact KENNETH L BLOCK
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIO  
JIR   JJB   JMT   JRE   LJX  
Date Received10/01/2009
Decision Date 12/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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